Dutch and Canadian researchers have found heroin-assisted treatment (HAT)
to be more effective than methadone-maintenance therapy in improving the
physiological health and functional outcomes of patients with chronic heroin
addiction who have relapsed from previous courses of methadone or
HAT refers to a type of treatment program in which chronically
heroin-addicted patients are given pharmaceutical-grade prescription heroin
under the supervision of trained medical personnel. HAT is provided in a
number of European countries including Switzerland, the Netherlands, and
At the annual meeting of the American Academy of Addiction Psychiatry held
last December in Boca Raton, Fla., Wim van den Brink, M.D., Ph.D., presented
findings from two randomized, open-label clinical trials on the effectiveness
of HAT that he and his colleagues at the Amsterdam Institute for Addiction
Research have conducted. He is the director of the institute and a professor
of psychiatry and addiction at the Academic Medical Center at the University
of Amsterdam. The results of the two studies were pooled and published in one
article in the January 2005 Addiction.
Patients in the two studies had an average of 16 years of heroin addiction
and 12 years of methadone treatment, had been refractory to past methadone
treatment, and had a high level of physical, psychiatric, and social
dysfunction. In one study, 174 patients with addiction to inhaled heroin were
randomized to either the conventional methadone treatment alone or methadone
plus medically prescribed heroin. In the other study, 375 patients were
randomized to either the methadone treatment or methadone plus injectable
All patients received oral methadone at a dose of no more than 150 mg a
day. Patients on inhaled or intravenous heroin were given heroin under medical
supervision no more than three times a day at a dose of no more than 400 mg
per administration and no more than 1,000 mg a day.
After pooling data from the two studies, the researchers found that 52
percent of patients receiving medically prescribed heroin plus methadone
achieved clinical response at the end of one year's treatment. This was
significantly higher than the 29 percent response rate in the group treated
with methadone alone. Clinical response was based on a multidomain index that
combined physical health, mental status, and social functioning assessments
and was defined as 40 percent improvement on any of the three scales, with no
serious deterioration. Patients receiving a medically supervised heroin
regimen had a sharp drop in illicit heroin purchase and use. Meanwhile, the
researchers observed no increased use of cocaine and other drugs. The average
amount of medically supervised heroin requested by the study patients was
found to be far below 1,000 mg a day, the maximum dose allowed by the
protocol, van den Brink pointed out.
Additional analyses of the study data indicate that overall HAT plus
methadone was also more cost-effective than methadone treatment to society, if
the legal costs of prosecuting illegal heroin use were taken into
consideration. He noted that clinical trials in Switzerland, Spain, the United
Kingdom, and Germany similarly supported the effectiveness of HAT.
Recently, a Canadian study comparing HAT with conventional methadone
treatment also generated positive outcome data similar to the European HAT
studies. The first-year results of the North American Opiate Medication
Initiative (NAOMI) study, released on October 17, 2008, showed that 88 percent
of patients randomized to HAT remained in the treatment program after 12
months, which was significantly higher than the 54 percent retention rate in
the methadone-maintenance treatment group. Patients' illicit heroin use and
involvement in illegal activities dropped substantially, while their medical
status improved. "The injectable treatment appears to be extremely
safe," the report concluded.
The study included 251 patients with chronic, treatment-refractory heroin
addiction in Vancouver and Montreal who had failed other treatments at least
twice. The patients were randomly assigned to either prescription heroin
injection treatment or oral methadone therapy. The oral methadone therapy was
optimized with a dose at least 50 percent higher than the community average.
The injections were given for 12 months and gradually tapered off over three
months. Patients were then transitioned to methadone, abstinence, or other
treatment programs and are being followed for two additional years.
"We now have evidence to show that heroin-assisted therapy is a safe
and effective treatment for people with chronic heroin addiction who have not
benefited from previous treatments," said Martin Schechter, M.D., Ph.D.,
the principal investigator of the NAOMI study and a professor and director at
the School of Population and Public Health at the University of British
Enrollment in the NAOMI study began in early 2005 and closed in spring
2007. By June 2008 all participants had completed treatment. All will be
monitored for two more years. The study is funded by the Canadian Institutes
of Health Research.
Van den Brink emphasized that "HAT is an effective option only if you
have easily accessible and [high-quality] methadone and buprenorphine
treatment programs." The availability of adequate methadone and
buprenorphine treatments in the United States lags behind that of Europe, he
indicated. To implement HAT programs also requires "full acceptance of
the harm reduction concept" by the medical community and the society
beyond the goal of abstinence only, which may pose cultural challenges.
"Supervised heroin-assisted treatment is not a first-line treatment.
It is the last resort," said van den Brink.
An abstract of "Matching of Treatment-Resistant
Heroin-Dependent Patients to Medical Prescription of Heroin or Oral Methadone
Treatment: Results From Two Randomized Controlled Trials" is posted at<www3.interscience.wiley.com/journal/118739139/abstract>.
Information about the NAOMI study and a report of results are posted at<www.naomistudy.ca>.▪